Public Citizen: Doc Groups Hedged Implants' Cancer Risk

WASHINGTON -- Two plastic surgeon groups instructed doctors to downplay the recently discovered link between breast implants and a rare cancer when talking to patients, according to the advocacy group Public Citizen.

Two physicians with Public Citizen -- Sidney Wolfe, MD, and Michael Carome, MD -- sent a letter to FDA officials Thursday explaining that a "concerned plastic surgeon" sent them a transcript from a members-only webinar in which the presidents of the two major plastic surgery organizations told their members to downplay the risk of a rare form of non-Hodgkin's lymphoma in women with breast implants.

The webinar was held on Feb. 3, a week after the FDA announced results from a review of more than 10 years of data that uncovered 34 cases of anaplastic large-cell lymphoma (ALCL) among women with breast implants, primarily the silicone-filled type.

The FDA cautioned that the link requires confirmation, and that it still believes FDA-approved breast implants are safe and effective.

In response to the FDA findings, Public Citizen charges, the presidents of the two major plastic surgery doctors' groups -- the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery -- hosted the webinar, during which they told their members to avoid characterizing ALCL as a "tumor" or a "cancer," when speaking with patients. Instead, patients should be told that breast implants have been linked to a rare "condition."

Public Citizen said it has a transcript in which Phil Haeck, MD, a Seattle-based plastic surgeon and president of ASPS, tells members: "[Y]es it's classically a malignant tumor, but it has such a benign course that when we were discussing ways to talk to the media, we decided that we would call this a condition when we talked to the media, not a tumor, not a disease, and certainly not a malignancy. Um, because, and I would recommend that you use the same terms with your patients rather than disturb them by saying this is a cancer, this is a malignancy. The best word is this is a condition."

Public Citizen criticized the groups for trying to mislead patients.

"In summary, two large national organizations representing plastic surgeons have attempted to trivialize the significance of the findings of increased numbers of cases of breast implant-related lymphomas," Wolfe and Carome wrote in their letter, addressed to FDA Commissioner Margaret Hamburg, MD, and the FDA's head of devices, Jeffrey Shuren, MD. "This campaign is misleading, dangerous, and unethical."

In a prepared statement from the American Society of Plastic Surgeons, the group said it had no intent of downplaying the issue.

"Far from intending to trivialize or minimize the issue, Dr. Haeck's extemporaneous remarks were well understood by the physicians present to mean that the type of ALCL that has been observed in possible association with breast implants does not appear to have the malignant course of classic ALCL which is a systemic disease. To be clear, our position is and has always been that ALCL associated with breast implants is a serious, but an extremely rare condition."

Haeck allegedly also instructed physicians on the webinar to tell patients that "surgery was curative" for ALCL.

"The scientific evidence to date suggests that ALCL associated with breast implants is a clinically indolent disease that behaves similarly to cutaneous ALCL and will therefore only require surgical removal of the implant and capsule and appropriate clinical follow-up," said the statement from the American Society of Plastic Surgeons.

Felmont Eaves, MD, the president of the other group -- the American Society for Aesthetic Plastic Surgery -- told MedPage Today that the partial transcript highlighted by Public Citizen was "cherry-picked" and taken out of context. However, he said that using advising doctors to use the word "condition" instead of "cancer" wasn't the "best wording."

Eaves said that the groups wanted to advise their members "so they will know how to handle things appropriately and how to talk to patients."

"No one is trying to say it's anything other than what it was defined as, which is ALCL," Eaves said.

During the webinar, plastic surgeons were told to explain to their patients that ALCL is very rare and that it is not breast cancer, Eaves said. (It's a lymphoma generally treated with chemotherapy.)

Data from the National Cancer Institute suggest that one in 500,000 women in the U.S. develops ALCL each year. ALCL in the breast is even more rare, an estimated three per 100 million women per year.

So far, there have been 34 cases of ALCL reported among the five to 10 million U.S. women who have received breast implants.

The FDA said it will review Public Citizen's letter and respond directly to the group.

"It's important that healthcare professionals and women who have breast implants or are considering breast implants are aware of FDA's recommendations on this issue," said FDA spokeswoman Erica Jefferson. "FDA continues to work with patient groups, breast implant manufacturers, and professional societies to ensure that women are adequately informed about this association so that they can make an educated medical decision."

In the days that followed the FDA's announcement in January, a number of plastic surgeons and a lymphoma specialist responded that 34 cases of ALCL among U.S. breast-implant users is not a reason for deep or widespread concern.

The American Society of Plastic Surgeons has announced plans to join with the FDA in establishing a breast implant registry to document adverse effects, including any additional cases of ALCL.

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